Position Summary:

ultracurious – Apply your biggest ideas in courageous ways

Looking for a highly motivated individual who has strong passion for science and pharmaceutical development, particularly for drug product and formulation development, as well as downstream process and clinical in-use activities. The ideal candidate will demonstrate curiosity and commitment to understanding the product lifecycle from preclinical formulation to manufacturing, and end-user product handling and administration. A drive for independent and cross-functional learning and collaboration is essential for this role. The role may involve direct management of team members and the cross-functional team. 

Work Model:

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.

Responsibilities:

1. Lead development and optimization of drug product processes for gene therapy products, including chromatography, ultrafiltration/diafiltration, formulation, mixing, filtration, filling, and freeze/thaw operations. 
2. Lead drug product (DP) process, formulation, characterization and clinical device development studies. 
3. Apply hands-on downstream development skills in the laboratory, designing and executing laboratory experiments, result analysis, documentation and presentations. 
4. Author and review technical protocols, study reports, investigation and scientific presentations, and generate, evaluate, and maintain data in a highly organized manner. 
5. Design and execute chromatography and purification experiments as necessary for formulation development, investigation, DP manual fill and finish for DP vial studies. 
6. Support the characterization of drug product manufacturing processes, including gap analysis, risk assessment, control strategy and investigation studies.    
7. Lead or support process parameter robustness study including impact analysis, studies of formulation and excipient impact on freezing, thawing, mixing, hold-time, filtering, filling and product contact on DP.  
8. Execute container characterization studies including primary container safety (extractables & leachables (E&L)) and impact analysis on product stability. 
9. Perform clinical device compatibility studies (Drug product with infusion sets, syringes, diluents). 
10. Support design and help with executing studies associated with drug product formulation stability, degradation pathway, container/closure compatibility, drug product hold-time, shipping, and handling robustness. 
11. Perform activities on developing formulation appropriate for various clinical administration methods (e.g., IV, SC, ICM, intrathecal), especially for novel modalities.   
12. Design, select, evaluate, and risk assess delivery devices (syringe pumps, catheters, IV sets, filters, etc.) and ancillary supplies by working with vendors and manufacturers. 
13. Support clinical readiness by developing or integrating rapid analytical tools (e.g., endotoxin testing, AAV genome titers, particulate matters, aggregation). 
14. Familiarity with ICH, ISO and FDA guidelines, CMC documentations including protocols, reports, and regulatory requirements for IND, IMPD, BLA/MAA. 

Requirements:

1. PhD or Master’s degree in Chemical or Biochemical Engineering, Biochemistry, Biology, Chemistry, Pharmaceutical, Pharmacy or related discipline. 
2. 5-8 years (PhD), 8+ years (Masters) relevant industry experience in drug product and formulation development.  
3. Hands-on pharmaceutical experience with drug product development for injectable therapeutics, including formulation process unit operations such as TFF, mixing, DS and DP filtration, DP filling and freezing / thawing.  
4. Hands-on experience of scale-up, tech transfer, and process characterization principles of the drug product manufacturing process at prior pharmaceutical companies.  
5. Experience with drug product container closure systems and clinical device compatibility and safety including extractable and leachable.   
6. Familiarity with hands-on or at least solid knowledge in formulation and drug product analytics, such as: subvisible particle analysis, viscosity, turbidity, dynamic light scattering, UV, A260/A280, Bilayer interferometry, differential scanning fluorometry, Size exclusion-HPLC, qPCR and mass photometry, and mass spectroscopy a plus. 
7. Knowledge of process development for upstream and downstream purification, including ability to run chromatography using AKTA and Unicorn systems.  
8. Excellent communication and documentation skills, and ability to work effectively, follow-through in a collaborative team environment, including close collaboration with MSAT, AD, QC and clinical development/operation. 
9. Demonstrate team spirit and collaboration, sharing resources, while being cognizant of roles, responsibilities and timelines of program needs. 
10. Individuals are independent, motivated, detail oriented and have good problem-solving ability. 

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